MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS; STENT, ILIAC

Catalog Number BXA095902A

Device Problems Detachment Of Device Component (1104); Physical Resistance (2578)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/19/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A review of the manufacturing records for the device verified the lot met all pre-release specifications.The gore® viabahn® vbx balloon expandable endoprosthesis instructions for use states if resistance is encountered upon attempted removal, do not force removal, use fluoroscopy and conventional techniques to determine and remedy the cause of resistance before proceeding.The balloon needs to be fully deflated to ensure it disengages fully from the endoprosthesis.

Event Description

The following information was reported to gore: on (b)(6) 2017 a patient underwent treatment of an internal iliac lesion with a gore® viabahn® vbx balloon expandable endoprosthesis.Access was obtained via an axillary artery through a 9fr x 70cm cook sheath.The device was advanced over a boston scientific meier wire, through a previously implanted gore® excluder® aaa endoprosthesis.When the device was near the target treatment zone, resistance was felt.It was decided this device would be removed.At this point the stent was beyond the distal end of the introducer sheath; the device felt like it was catching on something.The endoprosthesis became detached from the balloon.The endoprosthesis was then deployed right where it landed, in the common iliac artery.The delivery catheter and balloon were successfully removed from the patient.The internal iliac was coiled and embolized and the patient tolerated the procedure.

• Brand Name: GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS
• Type of Device: STENT, ILIAC
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• Manufacturer (Section G): MEDICAL ECHO RIDGE B/P; 3250 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: heidi inskeep ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 6761727
• MDR Text Key: 81903855
• Report Number: 2017233-2017-00393
• Device Sequence Number: 1
• Product Code: NIO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P160021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/23/2019
• Device Catalogue Number: BXA095902A
• Device Lot Number: 16426700
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/21/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 71 YR